What Is UDI?
The FDA's Unique Device Identification (UDI) system requires most medical devices distributed in the U.S. to carry a unique identifier on their label and packaging. The goal is to improve patient safety, streamline device recalls, and enhance post-market surveillance.
The Two Components of a UDI
Every UDI consists of two parts:
- Device Identifier (DI): A fixed portion that identifies the specific device version or model and the labeler.
- Production Identifier (PI): A conditional portion that includes lot/batch number, serial number, manufacturing date, and/or expiration date — depending on what appears on the label.
Who Needs to Comply?
UDI requirements apply to virtually all medical devices intended for commercial distribution in the U.S., with limited exceptions for:
- Devices that are exempt from labeling requirements
- Class I devices that are also exempt from design controls (with some caveats)
- Investigational devices
GUDID: The Global Unique Device Identification Database
In addition to labeling, manufacturers must submit device data to FDA's GUDID (Global Unique Device Identification Database). This public database allows healthcare providers, patients, and regulators to look up device information using the DI.
Key data points submitted to GUDID include:
- Device name and version
- Device identifier
- Labeler and contact information
- MRI safety status
- Implantable, single-use, and sterile flags
Compliance Deadlines by Device Class
FDA phased in UDI requirements over several years:
| Device Class | Compliance Required | |---|---| | Class III | September 2014 | | Class II | September 2016 | | Class I | September 2020 |
If your device was launched before these dates without UDI, you are already out of compliance and at risk during FDA inspections.
Choosing an Issuing Agency
FDA accredits three issuing agencies to assign Device Identifiers:
- GS1 — uses GTIN format
- HIBCC — uses HRI format
- ICCBBA — used primarily for blood and cellular products
Most medical device manufacturers use GS1.
Common UDI Compliance Mistakes
- Incorrect PI format — the production identifier must match exactly what appears on the label
- GUDID data not updated after a label or device change
- Missing UDI on direct marking for reusable devices
- Exemptions incorrectly claimed — always verify with FDA's UDI exemption list
How United Regulatory Can Help
We provide end-to-end UDI compliance services: issuing agency registration, GUDID submission and management, label review, and direct marking strategy for reusable devices. Contact us for a UDI compliance assessment.